1.6MM CROSS-CUT FISSURE CARBIDE BUR 2296101316

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2017-09-11 for 1.6MM CROSS-CUT FISSURE CARBIDE BUR 2296101316 manufactured by Stryker Instruments-kalamazoo.

Event Text Entries

[85638760] Awaiting device evaluation. A follow up report will be filed once the quality investigation is complete.
Patient Sequence No: 1, Text Type: N, H10


[85638761] It was reported that during a tooth extraction procedure, the tip of the bur broke at the point where it connects to the shaft. It was also reported that there were no delays and no adverse consequences as a result of this event. It was further reporte that the procedure was completed successfully.
Patient Sequence No: 1, Text Type: D, B5


[115089188] Investigation results indicate that the fractured part potentially failed due to overload conditions. A review of the label, #(b)(4) , indicated that the label displays an icon which equates to "do not use excessive force" using this device.
Patient Sequence No: 1, Text Type: N, H10


[115089189] It was reported that during a tooth extraction procedure, the tip of the bur broke at the point where it connects to the shaft. It was also reported that there were no delays and no adverse consequences as a result of this event. It was further reported that the procedure was completed successfully.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number0001811755-2017-01806
MDR Report Key6855067
Report SourceCOMPANY REPRESENTATIVE
Date Received2017-09-11
Date of Report2017-12-07
Date of Event2017-08-11
Date Mfgr Received2017-12-07
Device Manufacturer Date2017-04-28
Date Added to Maude2017-09-11
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR. UNA BARRY
Manufacturer StreetINSTRUMENTS DIVISION CARRIGTWOHILL BUS. & TECH PARK
Manufacturer CityCARRIGTWOHILL NA
Manufacturer PostalNA
Manufacturer Phone214532900
Manufacturer G1STRYKER INSTRUMENTS-IRELAND
Manufacturer StreetINSTRUMENTS DIVISION CARRIGTWOHILL BUS. & TECH PARK
Manufacturer CityCARRIGTWOHILL NA
Manufacturer Postal CodeNA
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand Name1.6MM CROSS-CUT FISSURE CARBIDE BUR
Generic NameBUR, DENTAL
Product CodeEJL
Date Received2017-09-11
Returned To Mfg2017-08-24
Catalog Number2296101316
Lot Number17118017
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerSTRYKER INSTRUMENTS-KALAMAZOO
Manufacturer Address4100 EAST MILHAM AVENUE KALAMAZOO MI 49001 US 49001


Patients

Patient NumberTreatmentOutcomeDate
10 2017-09-11

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